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    Clinical Trial Results:
    A Randomised Controlled Trial of Tumescent Anaesthesia in addition to Surgical Ligation and Stripping of the Great Saphenous Vein.

    Summary
    EudraCT number
    2011-005574-39
    Trial protocol
    GB  
    Global end of trial date
    30 Jan 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions
    Summary report(s)
    A randomised controlled trial of perivenous tumescent anaesthesia in addition to general anaesthesia for surgical ligation and stripping of the great saphenous vein

    Trial information

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    Trial identification
    Sponsor protocol code
    Surgery&TumescenceV3
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Hull University Teaching Hospitals NHS Trust
    Sponsor organisation address
    Anlaby Road, Hull, United Kingdom, HU3 2JZ
    Public contact
    Mr Tom Wallace, Academic Vascular Surgical Unit, Hull Royal Infirmary, +44 07789913071, tom.wallace@hey.nhs.uk
    Scientific contact
    Mr Tom Wallace, Academic Vascular Surgical Unit, Hull Royal Infirmary, +44 07789913071, tom.wallace@hey.nhs.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to evaluate the use of perivenous local anaesthesia during open SFJ ligation and GSV stripping. The hypothesis is that this could be associated with improvements in pain, QoL, and recovery to normal activities.
    Protection of trial subjects
    Full information about the study is shared in advance via the patient information sheet and participation is entirely voluntary. Ethics approval has been obtained.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 90
    Worldwide total number of subjects
    90
    EEA total number of subjects
    90
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    82
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Prior to introduction of UK NICE guidance CG168, patients were offered the intervention either endothermal ablation or surgery. Subsequent to July 2013, participants were offered surgery at surgeon or patient preference in a non-trialist clinic, where the anatomy was not favourable for endovenous procedure or guided by patient choice.

    Pre-assignment
    Screening details
    Inclusion criteria included adults with primary symptomatic SVI, CEAP grades C2–C6, suitable to undergo open surgical ligation and GSV stripping on Duplex ultrasound (DUS) assessment. Incompetence was defined as reflux of at least 0.5 s on spectral Doppler analysis

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject
    Blinding implementation details
    Patients were randomised by an online digital randomisation programme (www.sealedenvelope.com) after invitation to participate and prior to the procedure. The outcome of the randomisation was concealed from the participant. Patients were randomised to either a standard open surgical procedure under General Anaesthesia (GA) (GA Group) or to the addition of tumescent (G þ T group) once they had been listed for surgical management.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    GA Alone
    Arm description
    A standard open surgical procedure under General Anaesthesia (GA) (GA Group)
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    GA Plus Tumescent
    Arm description
    Under General Anaesthesia (GA) with the addition of tumescent (G & T group)
    Arm type
    Active comparator

    Investigational medicinal product name
    PR1 1% Lidocaine (Xylocaine) with 1:200,000 epinephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    The solution was made up of 900 ml of 0.9% sodium chloride solution with 100 ml of 1% lidocaine with 1:200,000 epinephrine added. Each bag of tumescent anaesthesia was for single-use only. The anaesthesia was administered using a pedaloperated peristaltic pump (Nouvag DP-20, Nouvag, Goldach, Switzerland) along the GSV (with PIN stripper in situ) with the use of DUS guidance, at a target of 10 ml per cm. Tumescent anaesthesia was also infiltrated into the groin incision and around all tributaries and perforators to be treated, this was performed by the operating surgeon, competent in DUS and endovenous ablative techniques. Patients in the control group received local anaesthesia consisting of 1% lidocaine with 1:200,000 epinephrine to the groin incision and stripper exit site only as per standard practice.

    Number of subjects in period 1
    GA Alone GA Plus Tumescent
    Started
    45
    45
    Completed
    45
    45

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GA Alone
    Reporting group description
    A standard open surgical procedure under General Anaesthesia (GA) (GA Group)

    Reporting group title
    GA Plus Tumescent
    Reporting group description
    Under General Anaesthesia (GA) with the addition of tumescent (G & T group)

    Reporting group values
    GA Alone GA Plus Tumescent Total
    Number of subjects
    45 45 90
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    42 40 82
        From 65-84 years
    3 5 8
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    28 29 57
        Male
    17 16 33

    End points

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    End points reporting groups
    Reporting group title
    GA Alone
    Reporting group description
    A standard open surgical procedure under General Anaesthesia (GA) (GA Group)

    Reporting group title
    GA Plus Tumescent
    Reporting group description
    Under General Anaesthesia (GA) with the addition of tumescent (G & T group)

    Primary: The bodily pain (BP) domain of SF-36 QoL tool

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    End point title
    The bodily pain (BP) domain of SF-36 QoL tool [1]
    End point description
    End point type
    Primary
    End point timeframe
    1 week
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Full Publication with results including statistical analysis included.
    End point values
    GA Alone GA Plus Tumescent
    Number of subjects analysed
    45
    45
    Units: 0-100
        number (not applicable)
    45
    45
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Investigators will notify HEY R&D of serious adverse events within 24hrs. HEY R&D will report fatal or life-threatening SUSARs to the MHRA within 7days and follow-up information within a further 8 days.
    Adverse event reporting additional description
    Adverse events will be reported in accordance with Hull and East Yorkshire Hospitals NHS Trust R&D (HEY R&D) Safety Reporting standard operating procedure (R&D GCP SOP 09) to ensure compliance with UK Clinical Trial Regulations.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Final published results attached.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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